Operations Regulatory CMC - Specialist

About the position
Do you have expertise in regulatory and overall understanding of GxP requirements? Are you highly collaborative and like contributing to clear instructions and implementing process improvements? This opportunity as Processes Specialist in the Regulatory Process and Compliance team might be the right opportunity for you.

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means putting patients first, doing the right thing and working together to make the impossible a reality. If you are swift to action, willing to collaborate, and curious about what science can do, then you’re our kind of person.

Responsibilities
As a Processes Specialist in the Regulatory Process and Compliance team you will be working with the Process team members and taking responsibility for the management of assigned tasks related to procedural document management. You will act as technical writer and reviewer, and support project management to ongoing procedural document update program.
You will be accountable to execute the delivery of the authoring and lifecycle management of current procedural documents. We hope that you have the drive to establish a culture of continuous improvement, high performance, flexibility and quality, emphasizing a “can do” attitude and ensuring high standards of quality in all outputs.

Other key responsibilities in this position:
• Identify opportunities for and drives the enhancement of existing processes and procedural documents
• Using understanding of regulatory processes and regulations to provide support to regulatory process team
• Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions
• Review and verify documents and data for accuracy and completeness
• Collaborate with team members to ensure high standards of quality in all outputs
• Contribute to communication and change management activities associated with process initiatives

Your profile
Essential for the role:
• A science/pharmacy/nursing degree, with relevant experience (pharmaceutical, regulatory, safety)
• Exceptional attention to detail and accuracy
• Excellent written and verbal communication skills in English
• Knowledge of the drug development process and sufficient knowledge to understand aspects of Regulatory
• Experience in working cross-functionally
• Proven ability to work across cultures

Desirable for the role:
• MSC/PhD in scientific discipline
• Knowledge of regulatory expectations and regulations
• Knowledge of existing AstraZeneca organisation
• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle

About the organisation
This is a consultant assignment at AstraZeneca in Göteborg from January 2025 until end of August 2025. During this time you will be hired by QRIOS.

About Astra Zeneca:
AstraZeneca is a major international healthcare company engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we are more than one of the world’s leading pharmaceutical companies - at AstraZeneca, we are proud to have a unique culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.